Modular apparatus for therapy of an animate body

ABSTRACT

A modular therapy system for treatment of at least a portion of an animate body is disclosed. The apparatus includes a first modular member and a second modular member. The first modular member comprises a heat transfer device adapted to transfer heat between the device and the portion of the animate body. The second modular member includes a pouch adapted to receive the first modular member. The second modular member can be wrapped around the animate body portion with the first modular member positioned therein. In various embodiments, the apparatus includes a third modular member having a pouch adapted to receive the first modular member. The third modular member is configured for wrapping to a different sized animate body or different portion of the body than the second modular member. The third modular member may have a different shape or size than the second modular member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 13/035,711, entitled “MODULAR APPARATUS FOR THERAPY OF AN ANIMATE BODY,” filed Feb. 25, 2011, now U.S. Patent Application Publication No. 2011-0152983, which is a continuation of U.S. patent application Ser. No. 10/848,097, entitled “MODULAR APPARATUS FOR THERAPY OF AN ANIMATE BODY,” filed May 17, 2004, now U.S. Pat. No. 7,896,910, the entire contents of which are incorporated herein for all purposes by reference.

FIELD

The present invention relates to therapy of an animate body, and more particularly to modular heat transfer apparatus for treatment of at least a portion of an animate body.

BACKGROUND

Cold packing with ice bags or the like traditionally has been used to provide deep core cooling of a body part. Elastic wraps are often applied to provide compression.

It will be appreciated that these traditional techniques are quite uncontrollable. For example, the temperature of an ice pack will, of course, change when the ice melts, and it has been shown that the application of elastic wraps and, consequently, the pressure provided by the same, varies considerably even when the wrappers are experienced individuals.

Because of these and other difficulties, many in the field have turned to more complicated animate body heat exchanger. Most effective animate body heat exchangers typically include two major components, an external compliant therapy component covering a body part to be subjected to heat exchange, and a control component for producing a flowing heat exchange liquid. Many control units also produce and supply an air or other gas pressure needed to apply pressure to a body part and to press the heat exchange liquid toward such body part. This air pressure is directed to another compliant bladder of the therapy component, which air pressure bladder overlays the liquid bladder to press such liquid bladder against the body part to be subjected to heat exchange, as well as apply compression to the body part to reduce edema.

As can be seen, a commonly used external therapy component uses a pair of compliant bladders to contain fluids; that is, it preferably has both a compliant bladder for containing a circulating heat exchange liquid and a gas pressure bladder which overlays the liquid bladder for inhibiting edema and for pressing the liquid bladder against the body part to be subjected to heat exchange. One problem is that in many therapy component configurations of this nature, the gas pressure bladder tends to “balloon” or, in other words, expand to a much greater degree than is desired. This unwanted expansion can be the cause of several problems. For one, it can actually pull away from the body part, some or all of the conformal heat exchange bladder. For another, it can reduce its edema inhibition ability, as well as reduce the desired effect of pressing the heat exchange bladder into contact with the body part.

Commonly used external therapy components use hook and loop fastening systems in order to allow the therapy component to be applied to a wide variety of body sizes and to give skilled users maximum flexibility in application. The hook and loop fastener is commonly a permanent and integral part of the therapy component, and can be attached by a variety of means including but not limited to sewing, RF welding, gluing, and heat sealing. There are several problems with the permanent attachment of a hook and loop fastening system to the therapy component. First, forces may resolve disadvantageously when the hook and loop fastener is secured, which can result in peeling the hook and loop fastener open and decreasing effective compression. Second, a sewn assembly is relatively stiff, resulting in less even distribution of compression therapy, as well as a higher probability of folds in the assembly that can cause fluid flow to be cut off as compression increases. Third, the therapy component is typically in direct contact with the skin, but RF welded soft heat exchangers cannot be machine washed making it more difficult to provide sanitary treatment in clinical settings or in rental situations. Finally, hook and loop fasteners have a limited lifetime and when they wear out, the entire therapy component must be scrapped.

There remains a need to provide efficient heat transfer therapy apparatus and methods.

SUMMARY OF THE DISCLOSURE

The present invention involves improvements in heat transfer therapy apparatus and avoids disadvantages in the prior art.

According to one embodiment of the invention, a modular therapy apparatus for treatment of at least a portion of an animate body comprises a first modular member comprising a heat transfer device adapted to transfer heat between the device and the at least a portion of an animate body; and a second modular member forming a pouch having a perimeter and adapted to receive the first modular member, the second modular member comprising a front side and a back side, the front side having a hook portion, which forms the hook portion of a hook and loop fastener, the back side having a loop portion, which forms the loop portion of the hook and loop fastener, whereby the second modular member can be wrapped around the at least a portion of an animate body and the hook and loop portions fastened to one another to secure the second modular member with the first modular member positioned therein to the at least a portion of the animate body. Among the many advantages of the invention is that it can improve effective delivery of therapy.

Various aspects of the invention are directed to a modular therapy apparatus for treatment of at least a portion of an animate body comprising a first modular member comprising a heat transfer device adapted to transfer heat between the device and at least a portion of the animate body; and a second modular member forming a pouch having a perimeter and adapted to receive the first modular member, the second modular member comprising a front side and a back side, the front side having a hook portion, which forms the hook portion of a hook and loop fastener, the back side having a loop portion, which forms the loop portion of the hook and loop fastener, the loop portion being non-stretch material.

Various aspects of the invention are directed to a modular therapy apparatus for treatment of an animate body comprising a first modular member comprising a heat transfer device adapted to transfer heat between the device and the animate body, the heat transfer device comprising a first bladder and a second bladder; the first bladder adapted to circulate a coolant and the second bladder being inflatable; and a second modular member forming a pouch having a perimeter and adapted to receive the first modular member, the first and second modular members being removable from one another after the first modular member has been placed in the pouch.

Various aspects of the invention are directed to a modular therapy system for treatment of an animate body comprising a first modular member comprising a heat transfer device adapted to transfer heat between the device and the animate body, the heat transfer device comprising a first bladder for circulating coolant and a second bladder that is inflatable; a coolant source fluidly coupled to the first bladder; a gas source fluidly coupled to the second bladder; and a second modular member forming a pouch having a perimeter and adapted to receive the first modular member, the first and second modular members being removable from one another after the first modular member has been placed in said pouch.

Various aspects of the invention are directed to a system for treatment of differently sized animate body members comprising a first modular member comprising a heat transfer device; a second modular member forming a pouch having a perimeter and adapted to receive the first modular member, the second modular member comprising a front side and a back side, the front side having a hook portion, which forms the hook portion of a hook and loop fastener, the back side having a loop portion, which forms the loop portion of the hook and loop fastener; and a third modular member forming a pouch adapted to receive the first modular member; the second modular member comprising a front side and a back side, the front side having a hook portion, which forms the hook portion of a hook and loop fastener, the back side having a loop portion, which forms the loop portion of said hook and loop fastener, the third modular member pouch having the same configuration and size as the second modular member pouch and the third modular member being larger than the second modular member.

Various aspects of the invention are directed to a system for treatment of differently sized animate body parts including a first modular member comprising a heat transfer device; a second modular member forming a pouch having a perimeter and adapted to receive said first modular member, said second modular member comprising a front side and a back side, said front side having a hook portion, which forms the hook portion of a hook and loop fastener, said back side having a loop portion, which forms the loop portion of said hook and loop fastener; and a third modular member forming a pouch adapted to receive said first modular member; said third modular member comprising a front side and a back side, said front side having a hook portion, which forms the hook portion of a hook and loop fastener, said back side having a loop portion, which forms the loop portion of said hook and loop fastener, said third modular member pouch having the same configuration and size as said second modular member pouch and said third modular member being larger than said second modular member.

In various embodiments, the loop portions are non-stretch material. In various embodiments, the first modular member comprises a bladder. In various embodiments, the first modular member comprises a plurality of bladders. The bladders may form separate chambers.

Various aspects of the invention are directed to a system for providing thermal therapy to a portion of an animate body, the system including a first modular member comprising a heat transfer device; a second modular member comprising a pouch adapted to receive the first modular member; and a third modular member comprising a pouch having the same configuration and size as the second modular member pouch, wherein the third modular member and the second modular member are configured for wrapping to differently sized body portions.

In various embodiments, the second modular member is sized and configured for application to an arm and the third modular member is sized and configured for application to a leg. In various embodiments, the second modular member is sized and configured for application over an elbow and the third modular member is sized and configured for application over a knee. In various embodiments, the third modular member is larger than the second modular member. In various embodiments, the third modular member is shaped differently than the second modular member. In various embodiments, the third modular member has an extra seam. The third modular member may have a width at least one inch greater than a width of the second modular member. The third modular member may have a width between about 1 inch and about 12 inches greater than a width of the second modular member. An area of a side of the third modular member may be between about 1 square feet and about 6 square feet. An area of a side of the second modular member may be between about 1 square feet and about 1.5 square feet. An area of a side of the third modular member may be about 6 square feet or less. An area of a side of the third modular member may be about 10 square feet or less.

In various embodiments, the first modular member is movable within the pouches of the second modular member and third modular member when the pouches are closed. In various embodiments, the heat transfer device includes a plurality of bladders. The bladders may form separate chambers of the heat transfer device. In various embodiments, the heat transfer device comprises a fluid bladder for circulating a cooled fluid and an inflatable bladder for applying a compressive force to the different anatomical body parts. In various embodiments, a fluid source is fluidly coupled to the fluid bladder and a gas source fluidly coupled to the inflatable bladder. In various embodiments, the second modular member pouch includes an opening between at least two regions of the second modular member and a fastener for fastening the opening closed. The opening may be formed along a peripheral edge of the second modular member.

In various embodiments, the second modular member pouch is adapted to receive two or more heat transfer devices. In various embodiments, the third modular member pouch is adapted to receive two or more heat transfer devices. The two or more heat transfer devices may be secured in the pouch using one of the above techniques.

In various embodiments, the second modular member includes a front side and a back side, the front side having a hook portion which forms the hook portion of a hook and loop fastener, and the back side having a loop portion which forms the loop portion of the hook and loop fastener of the second modular member; and wherein the third modular member includes a front side and a back side, the front side having a hook portion which forms the hook portion of a hook and loop fastener, and the back side having a loop portion which forms the loop portion of the hook and loop fastener of the third modular member. The loop portions of the second and third modular members may be non-stretch material.

Various aspects of the invention are directed to a modular therapy apparatus for treatment of an animate body including a first modular member comprising a heat transfer device adapted to transfer heat between the device and the animate body, the heat transfer device comprising a first bladder and a second bladder, the first bladder adapted to circulate a coolant and the second bladder being inflatable; and a second modular member forming a pouch having a perimeter and adapted to receive said first modular member. The first and second modular members may be removable from one another after the first modular member has been placed in the pouch. In various embodiments, the first and second bladders form separate chambers. In various embodiments, the first bladder includes an inlet port and an outlet port and the second bladder includes a port.

In various embodiments, the second modular member pouch includes an opening. The opening may be formed along the perimeter of the second modular member. The second modular member pouch may include a fastener for fastening the opening closed. In various embodiments, the fastener is a zipper fastener arranged in the vicinity of the opening for selectively opening and closing the opening.

Various aspects of the invention are directed to a modular therapy apparatus for treatment of an animate body including a first modular member including a heat transfer device adapted to transfer heat between the device and the animate body, the heat transfer device comprising a first bladder and a second bladder, the first bladder adapted to circulate a coolant and the second bladder being inflatable to apply a compressive force to the animate body; and a second modular member forming a pouch having a perimeter and adapted to receive said first modular member. The first and second modular members may be removable from one another after the first modular member has been placed in the pouch.

In various embodiments, the first and second bladders form separate chambers. The first bladder may include an inlet port and an outlet port and the second bladder may include a port. The second modular member pouch may include an opening. The opening may be formed along the perimeter of the second modular member. In various embodiments, the second modular member pouch includes a fastener for fastening the opening closed. The fastener may be a zipper fastener arranged in the vicinity of the opening for selectively opening and closing the opening.

In various embodiments, the second modular member includes a front side and a back side, the front side having a hook portion which forms the hook portion of a hook and loop fastener, and the back side having a loop portion which forms the loop portion of the hook and loop fastener of the second modular member. The loop portion may comprise non-stretch material. The loop portion may include a loop material secured to a non-stretch backing material. The non-stretch backing material may be nylon.

In various embodiments, the second bladder is configured to be inflated to a pressure between about 0.25 psig and about 1.5 psig. The first bladder and the second bladder may be defined by a pair of generally parallel walls sealed together along their perimeters.

Various aspects of the invention are directed to a method of assembling a heat transfer apparatus for a portion of an animate body, the method including selecting a sleeve from among a plurality of sleeves based on a body portion to which the sleeve is intended to be applied, each of the plurality of sleeves comprising a pouch; and inserting a heat transfer device into the pouch of the selected sleeve, the heat transfer device comprising a bladder for carrying a heat transfer medium. In various embodiments, the method further includes removing the heat transfer device and selected another sleeve from among the plurality of sleeves. The method may include inserting the heat transfer device into the another sleeve. The method may include inserting another heat transfer device into the another sleeve. In various embodiments, the method includes inserting two or more heat exchangers into one or any of the sleeve pouches.

In various embodiments, the pouches of the plurality of sleeves have substantially the same size and dimensions, the size and dimensions corresponding to the heat transfer device. In various embodiments, the method further includes providing a plurality of heat transfer devices of substantially the same size, wherein the inserted heat transfer device is selected from among the plurality of heat transfer devices. Each of the plurality of sleeves may have a different size, and the selecting of the sleeve may be based on the size of the anatomical body part. In various embodiments, each of the plurality of sleeves has a different shape, and the selecting of the sleeve is based on the shape of the anatomical body part. In various embodiments, the method further includes mechanically fastening the heat transfer device in the pouch. In various embodiments, the method further includes after the inserting, removing the heat transfer device; and selecting another sleeve from among the plurality of sleeves; and inserting the heat transfer device into the pouch of the selected another sleeve.

Various aspects of the invention are directed to a method of assembling heat transfer apparatus for an animate body comprises providing a plurality of same sized bladders adapted for carrying heat transfer medium; providing a plurality of differently sized covers each with a pouch, wherein the pouches are of the same size and are adapted to receive a respective one of the bladders; selecting a cover; and inserting one of the bladders in the pouch of the selected cover.

Various aspects of the invention are directed to a method of assembling a heat transfer apparatus for a portion of an animate body, the method including selecting a sleeve from among a plurality of sleeves based on a body portion to which the sleeve is intended to be applied, each of the plurality of sleeves comprising a pouch; and inserting a heat transfer device into the pouch of the selected sleeve, the heat transfer device comprising a bladder for carrying a heat transfer medium.

In various embodiments, the pouches of the plurality of sleeves have substantially the same size and dimensions, the size and dimensions corresponding to the heat transfer device. The method may include providing a plurality of heat transfer devices of substantially the same size, wherein the inserted heat transfer is selected from among the plurality of heat transfer devices. Each of the plurality of sleeves may have a different size, the selecting of the sleeve being based on the size of the animate body part. Each of the plurality of sleeves may have a different shape, the selecting of the sleeve being based on the shape of the animate body part.

In various embodiments, the method includes mechanically fastening the heat transfer device in the pouch. In various embodiments, the method includes, after the inserting, removing the heat transfer device; selecting another sleeve from among the plurality of sleeves; and inserting the heat transfer device into the pouch of the selected another sleeve.

Various aspects of the invention are directed to a method of assembling a heat transfer apparatus for an animate body including providing a plurality of same sized heat transfer devices comprising bladders adapted for carrying a heat transfer medium; selecting a cover from among a plurality of differently sized covers based on an animate body, each of the plurality of covers including a pouch, wherein the pouches are of the same size and are adapted to receive the plurality of bladders; and inserting one of the bladders in the pouch of the selected cover.

Various aspects of the invention are directed to a method of assembling a heat transfer apparatus for a portion of an animate body, the method including providing a first modular member comprising a heat transfer device, the heat transfer device comprising a first bladder and a second bladder, the first bladder adapted to circulate a coolant to transfer heat between the device and the animate body and the second bladder being inflatable to apply a compressive force to the animate body; and inserting the first modular member through an opening into a pouch in a second modular member, the second modular member pouch including at least two regions with the opening between the at least two regions and a fastener for fastening the opening closed.

In various embodiments, the method includes fastening the opening closed. The selecting of the second modular member may include selecting one of a plurality of second modular members based on the animate body to which the apparatus is to be applied. The second modular member may include a front side and a back side, the front side having a hook portion which forms the hook portion of a hook and loop fastener, and the back side having a loop portion which forms the loop portion of the hook and loop fastener of the second modular member, wherein the loop portion comprises non-stretch material. In various embodiments, the method includes inflating the second bladder to a pressure between about 0.25 psig and about 1.5 psig.

The above is a brief description of some deficiencies in the prior art and advantages of the present invention. Other features, advantages, and embodiments of the invention will be apparent to those skilled in the art from the following description and accompanying drawings, wherein, for purposes of illustration only, specific forms of the invention are set forth in detail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the invention;

FIG. 2 illustrates top plan views of modular portions of the embodiment of FIG. 1;

FIG. 3 illustrates bottom plan views of the modular portions of FIG. 2;

FIG. 3A is an enlarged section of a portion of one of the modular portions of FIG. 3 illustrating a dot connection pattern;

FIG. 4 illustrates coupling the modular portions of FIG. 2;

FIG. 5A illustrates the modular portions of FIG. 4 with one modular portion enclosed in a pouch in the other or outer modular portion;

FIG. 5B illustrates a variation of FIG. 5A where the inner enclosed portion has the same dimension and the outer modular portion, which encloses the inner modular portion, is larger;

FIG. 6 is a sectional view taken along line 6-6 in FIG. 5A;

FIGS. 6A and 6B diagrammatically illustrate the true grain orientation of the heat transfer device layers illustrated in FIG. 6 in accordance with one embodiment of the invention;

FIGS. 7A-C illustrate use of the embodiment of FIG. 1, where FIG. 7A illustrates applying the apparatus to the arm of a human user; FIG. 7B illustrates the apparatus wrapped around the arm; and FIG. 7C illustrates the apparatus wrapped around the lower portion or calf of the user;

FIG. 8 illustrates another embodiment of the invention;

FIGS. 9A-B illustrate use of the embodiment of FIG. 8, where FIG. 9A illustrates the apparatus being wrapped around a human patient's upper leg and knee and FIG. 9B illustrates the apparatus fully wrapped around that region and ready for use;

FIG. 10 illustrates bottom plan views of modular portions of another embodiment of the invention which, for example, is suitable for coupling to the patient's body core region;

FIG. 11 illustrates top plan views of the modular portions of FIG. 10;

FIG. 12 is a sectional view of the embodiment of FIG. 10 with the modular portions coupled;

FIG. 13A illustrates coupling of the modular portions so that one modular portion is enclosed in a pouch in the other or outer modular portion;

FIGS. 13B and 13C show two positions of the embodiment of FIG. 10 after insertion of the one modular portion as shown in FIG. 13A, wherein FIG. 13B shows the belt or strap portions arranged downward and FIG. 13C show the belt or strap portions arranged upward;

FIGS. 14A-D diagrammatically depict use of the embodiment of FIG. 10 where FIG. 14A show a first step in wrapping the apparatus around the waist of a patient, FIG. 14B shows securing the apparatus in place, FIG. 14C shows the apparatus being in its final position and ready for use, and FIG. 14D shows the apparatus with the straps repositioned and the apparatus being wrapped around the upper torso of the patient;

FIG. 15 illustrates another embodiment of the invention, which, for example, can be used to treat the ankle and foot region of a patient;

FIG. 16 illustrates top plan views of modular portions of the embodiment of FIG. 15;

FIG. 17 illustrates bottom views of the modular portions of FIG. 16;

FIGS. 18A-C illustrate coupling the modular portions of the embodiment of FIG. 16. where FIG. 18A illustrates a first stage of inserting one modular portion into the other modular portion, FIG. 18B illustrates another stage of inserting the one modular portion into the other, and FIG. 18C illustrates the one modular portion fully inserted into the other modular portion;

FIGS. 19A-D illustrate use of the embodiment of FIG. 10, where FIG. 19A shows a first stage in wrapping the device; FIG. 19B illustrates securing mating hook and loop fastener portions around the foot; FIG. 19C illustrates securing mating hook and loop fastener portions at the forward portion of the lower leg of the patient, and FIG. 19D illustrates securing mating hook and loop fastener portions behind the ankle and region adjacent thereto;

FIG. 20 illustrates another embodiment of the invention, which, for example, can be used to treat the shoulder of a patient;

FIG. 21 illustrates top views of modular portions of the embodiment of FIG. 20;

FIG. 22 illustrates bottom views of the modular portions of FIG. 21;

FIGS. 23A-D illustrate coupling the modular portions of FIG. 20, where FIG. 23A illustrates a first stage where the modular portions are generally aligned, FIG. 23B illustrate inserting a portion of one modular portion into the other modular portion, FIG. 23C illustrates another stage where the one modular portion is fully positioned in the other, and FIG. 23D illustrates edges or flaps of the covering modular portion secured to enclose the other modular portion;

FIGS. 24A-D diagrammatically illustrate use of the embodiment of FIG. 20 where FIG. 24A shows a first stage in pulling the apparatus over the arm and toward the shoulder of a patient, FIG. 24B illustrates wrapping the apparatus around the shoulder of the patient and securing mating hook and loop fastener portions around the arm; FIG. 24C illustrates securing mating hook and loop fastener portions to secure portions that wrap around the chest of the patient, and FIG. 24D illustrates the apparatus in position for use with an optional strap having one end attached to the apparatus and mating hook and loop fastener portions secured to one another to form a loop for receiving the patient's arm;

FIG. 25 illustrates another embodiment of the invention, which can be used in equine applications;

FIG. 26 illustrates bottom views of modular portions of the embodiment of FIG. 25;

FIG. 27 illustrates top views of the modular portions of FIG. 25;

FIG. 28 is an elevation view of the interior of the heat exchange liquid bladder of a vest therapy component of the preferred embodiment; and

FIG. 29 is an elevation view showing the interior of the gas pressure bladder of the vest component.

DETAILED DESCRIPTION

Before the present invention is described, it is to be understood that this invention is not intended to be limited to particular embodiments or examples described, as such may, of course, vary. Further, when referring to the drawings, like numerals indicate like elements.

This application is related to U.S. application Ser. No. 12/208,240 filed Sep. 10, 2008, published as U.S. Pub. No. 2009/0005841, which is incorporated herein for all purposes by reference.

The invention comprises modular heat transfer therapy apparatus, which includes a first modular member or portion and a second modular member or portion. The first modular member or portion comprises a heat transfer device and the second modular member portion forms a pouch in which the first modular member is placed. The first modular member can be readily removed so that one can clean either or both the first and second modular members and/or replace either of the first and second modular members. For example, the second modular member can be constructed of material so that it is washable and reusable so that the second modular member can be cleaned after being stained with blood or otherwise soiled. This can happen, for example, when there is blood in the area of the portion of the animate body being treated. Alternatively, the second modular member can be made so that it is a low-cost single-user disposable product. The ability to remove the first modular member from the second modular member and clean or replace the latter is especially advantageous when the apparatus is used on different patients. Further, one can replace the first or second modular member when portions thereof are beginning to fail after a long period of use. With this construction, a faulty heat exchanger can be easily replaced. The ability to replace one modular member also can avoid the need to dispose of the entire apparatus, thereby providing the ability to reduce cost over time. The following description, which will readily make apparent many other advantages of the invention, pertains to illustrative examples and is not provided to limit the invention.

Referring to FIG. 1, a perspective view of one embodiment of the invention is shown and generally designated with reference numeral 100. Modular heat transfer therapy apparatus 100 generally comprises first modular member 102 and second modular member 104, which forms a cover for the first modular member. In the illustrated embodiment, second modular member 104 is in the form of a sleeve. In other words, apparatus 100 is adapted to be wrapped around at least a portion of a patient's body and form a sleeve around that portion. In the illustrated embodiment, first modular member 102 is a heat exchange device.

In FIG. 1, first modular member 102 is inside the second modular member 104 and hidden from view. In the illustrative embodiment, first modular member 102 comprises two compliant bladders, outer bladder 106 (FIG. 2) and inner bladder 108 (FIG. 3), which form separate chambers such as chambers 106 a and 108 a for different fluids. Compliant bladders 106 and 108 are generally parallel to one another (see FIG. 6) and are made so as to preclude fluid communication therebetween or between chambers 106 a and 108 a during use. Bladders 106 and 108 can be formed from three sheets of material with one forming a common inner wall for chambers 106 a and 108 a as will be described in more detail below.

More specifically, outer bladder 106 is adapted to receive a first fluid such as a gas (e.g., air), which can be regulated to provide the desired amount of inflation of the bladder or pressure therein. This inflation or pressure affects the compressive force applied to the animate body during use as will be further described below. Inner bladder 108 is adapted to receive a fluid, such as a coolant, which can be in the form of a cold liquid, to transfer heat away from the animate body part. Alternatively, the fluid supplied to inner bladder 108 can have a temperature higher than ambient so as to heat the animate body part. In the example illustrated in FIG. 1, a three port manifold 110 provides a port for a fluid such as air to be introduced and exhausted from bladder 106 and fluid inlet and outlet ports for circulating fluid through bladder 108. Each port is formed by a tubular member, which has one end adapted to receive a hose connector as is known in the art and another end adapted to be inserted into one of three tubes (not shown) extending from the bladder (described below). Further, each of the manifold fluid inlet and fluid outlet tubular members or passageways can be provided with a valve such as a spring loaded valve that is configured to allow the passage of fluid therethrough when the fluid hose connectors are coupled to the manifold and to prevent fluid flow therethrough when the fluid hose connectors are uncoupled from the manifold as is known in the art. In this manner, fluid such as a liquid coolant is blocked from exiting fluid bladder 108 when the fluid hoses are uncoupled from the manifold. The gas port does not include a valve. As described above, there are three tubes extending from the bladders. One tube extends from bladder 106 and two tubes extend from bladder 108. The tubes extending from bladder 108 can be placed adjacent to the tube extending from bladder 106 with the tube for bladder 106 above and between the tubes for bladder 108. In manufacture, bladder 106 is formed with an opening and bladder 108 is formed with two openings to receive the tubes in the orientation described above. A tube, such as a polyurethane tube, is positioned in each one of these openings and then welded to a respective bladder to form a fluid tight seal therewith. The tubes extending from the bladders typically have an inner diameter of about ⅛ inch. The manifold passageways typically have a diameter of about ¼ inch. Manifold 110 can be inserted into the tubes to form a seal therewith. For example, each manifold tubular member end portion that mates with or is inserted into a respective tube extending from one or the other bladder can be provided with tapered hose barbs to enhance the seal as is well known in the art. A suitable manifold construction is disclosed in U.S. Pat. Nos. 5,104,158 and 5,052,725, both to Meyer, et al. and both entitled Two Piece Female Coupling. The disclosures of U.S. Pat. Nos. 5,104,158 and 5,052,725 are hereby incorporated herein for all purposes by reference. The manifold, which carries or forms the tubular members, can be configured to mate with the curves of the body when connected to the modular apparatus. It also can be provided with a ridge for finger placement to allow easier removal. A fluid circulation control unit as diagrammatically represented in FIG. 7B and generally designated with reference numeral 180 is coupled to manifold 110 with tubing to fluidly communicate the therapy fluids to bladders 106 and 108 as will be described in more detail below. It should be understood that other manifold configurations and/or couplings to provide fluid flow between the fluid source and the bladders can be used as would be apparent to one of skill in the art. For example, valves need not be provided in the liquid port couplings.

Referring to FIG. 6, further details of one embodiment of the heat exchange device or first modular member will be described. In various respects, the heat transfer device is similar to those described in U.S. Pat. No. 6,695,872, incorporated herein for all purposes by this reference. FIGS. 28 and 29 show an arrangement for the bladders of the vest garment therapy component similar to that of the cap component. With reference to FIG. 28, the border 51 of the heat exchange bladder 52 is defined by curvilinear ripples. Liquid is introduced into the bladder via inlet tube 53, flows throughout the bladder along a path defined by fences 54, and exits through exit tube 56. A matrix of dot connections 57 is provided throughout the interior to disperse the liquid and assure that all aspects of the torso are subjected to the heat exchange liquid.

The interior of the gas pressure bladder 61 is represented in FIG. 29. The border 62 is defined by curvilinear ripples which register with those of the liquid bladder, and air pressure is introduced into the same via tube 63. Such gas pressure bladder includes a fence configuration 64 which acts as the connections within the bladder between the walls. This fence configuration registers with the fence configuration in the liquid bladder shown in FIG. 28, with both this configuration and the fences in FIG. 28 being simultaneously formed by heat sealing in accordance with the manufacturing process discussed above for the cap therapy component. In this connection, the sheets of material from which the two bladders of the vest component are formed are heat sealable coated nylon. It is to be noted that in this arrangement, the dot connections are not also provided in the air pressure bladder.

Returning to FIG. 6, the illustrative heat transfer or heat exchange device includes compliant bladder 108, which circulates heat exchange fluid or liquid. This bladder is defined by a pair of generally parallel, flexible, or in other words, compliant, and fluid- or liquid-tight, walls or layers of material 152 and 154, which walls are sealed together by, for example, RF welding along their perimeters. Compliant gas pressure bladder 106 which overlays heat exchange bladder 108 as illustrated to direct gas (most simply, air) pressure against the heat exchange bladder 106 to press it towards the portion of the body being treated. This compliant gas pressure bladder 106 is also defined by a pair of generally parallel and flexible walls or layers of material 150 and 152. In this embodiment, wall 152 is a common wall, i.e., one side of the same aids in defining gas pressure bladder 106 whereas the other side aids in defining bladder 108. Thus, three compliant walls or sheets of material are all that is necessary to define the two separate bladders. Wall or layer 150 is also secured to walls 152 and 154 via RF welding along its perimeter.

The connections in the interior of heat exchange liquid bladder 108 include a relatively uniform distribution of dot connections as shown in FIG. 3A and designated with reference character “D.” This matrix of connections acts to disperse the liquid throughout the bladder. This dispersion is further aided by curvilinear fence connections provided for the purpose of directing the flow of a liquid. These fence connections are indicated by the reference numeral F in FIG. 3A. In the illustrative embodiment, the dots are formed in a triangular grid. As used herein, “dot” and “fence” are to be understood as generally used in the art. In various respects, “dots” and “dot connections,” and “fences” and fence connections,” are used interchangeably. The singular includes the plural and vice versa.

During the manufacturing process, sheets of material defining the walls 152 and 154 are RF welded together at the dot connections and at the interior fences. At a later time, the wall 150 is RF welded to the other walls at the perimeter of the bladder. This RF welding will also form a common border for walls 150, 152, and 154. In various embodiments, the dots and fences are welds. The dots may be spot welds and the fences may be linear or curvilinear welds.

Referring to FIGS. 6A and 6B, the heat transfer or heat exchange device is welded with each of the three layers having a rotated true grain of about 10-30° with respect to one another. This grain rotation can dramatically improve resistance to ripping of the heat exchanger. In the embodiment illustrated in FIG. 6B, sheets 150, 152 and 154 have grain directions indicated with arrows “A,” “B” and “C,” respectively. Grain direction B of sheet 152 is offset in a counterclockwise direction from grain direction A of sheet 150 by about 30°. And grain direction C of sheet 154 is offset in a clockwise direction from grain direction A of sheet 152 by about 30°.

Each of the walls 150, 152 and 154 can be made of a nylon material suitably coated with polyurethane to provide both the RF welding qualities and the needed liquid or air impermeability. In one embodiment of the invention, the heat transfer or heat exchange device can comprise fabrics (e.g., nylon fabric) that are laminated with asymmetric amounts of polyurethane. That is, the inner surface of the outer wall of the coolant chamber has an extra heavy coating, which corresponds to about a 5 oz coating of polyurethane, while the inner surfaces of the other walls have standard coatings corresponding to about 3 oz coatings of polyurethane. Accordingly, the surfaces of the inner wall of the coolant and air chambers and the inner surface of the outer wall of the air chamber have standard 3 oz coatings. This construction only requires one non-standard fabric (the fabric having the 5 oz coating), while providing the extra polyurethane necessary to produce an extremely robust weld capable of taking or withstanding over 25,000 cycles at 30 psi. This construction can reduce manufacturing costs. It also facilitates using a lighter weight fabric, which can result in a more flexible heat exchanger that can better fit to the body. In another embodiment of the invention, the inner wall of the coolant chamber has a 5 oz coating of polyurethane in order to facilitate a yet stronger bond at the expense of increased manufacturing costs due to the use of a second non-standard fabric. A finish on the nylon material can also provide a permanent antimicrobial finish to prevent mold growth.

Referring to FIGS. 2 and 3, top plan and bottom views of second modular member 104 are shown. Modular member 104 comprises an inner or front side portion 112 and an outer or back side portion 114. Member 104 can be made from various materials and can comprise inner and outer sheets of material that are sewn or fused together. For example, the inner and outer sides can comprise two sheets of fabric, which are sewn together to form seam 116. An additional seam 118 is provided so that seams 116 and 118 form flap or marginal portion 120 and the perimeter of pouch 122, which is adapted to receive first modular member 102. Binding can be provided around the perimeter of second modular member 104 as shown in FIG. 6.

Outer back side portion 114 of second modular member has an opening 124 formed therein for receiving first modular member 102 as shown in FIG. 4. A portion of back side 114, such as portion 126, can be pulled back (FIG. 2) to facilitate positioning the remaining portion of first modular member 102 into the pouch. Numeral 114 a indicates the inner surface of back side portion 114 and is shown in the inner surface portion 126. Any suitable fastening means can be used to close opening 124. For example, zipper 127 can be provided along the sides of the opening. One will understand from the description herein that the opening for the pouch and pouch configuration may be modified depending on the application. For example, the opening may be positioned along a peripheral edge of the second modular member or along a seam.

Second modular member 104 also includes a fastener for holding the apparatus in the desired location on the animate body. Accordingly, when the apparatus is wrapped around a portion of or the entire region being treated, the fastener holds the apparatus in place during treatment. In the illustrative embodiment, a hook and loop fastener is used. Accordingly, if the hook and loop fastener wears out, the removable second modular member or sleeve can be readily replaced.

Referring to FIG. 2, the loop material portion 128 of the hook and loop fastener can be integrally formed with or placed over essentially all of outer back side portion 114 of second modular member 104. Alternatively, a strip of loop material can be integrally formed with or placed over a portion or the entire length (measured from the upper to lower edge of member 104 while referring to FIG. 2) of outer back side portion 114 along the side opposite flap 120. The hook material portion of the hook and loop fastener is shown in FIG. 3 and generally designated with reference numeral 130. Hook portion 130 can be in the form of a single strip that extends along the height of inner front side portion 112 (measured from the upper to lower edge, of inner front side portion 112) or it can be integrally formed with front side portion 112 in the same region. It can extend about 50% to 100% of the length of portion 112. Alternatively, hook portion can comprise a plurality of strips, which can be spaced along the length of portion 112.

In the illustrative embodiment, the active areas of the hook and loop fastener are outside the seams forming pouch 122. When compression increases, the forces may tend to resolve as shear forces as compared to other forces that can peel the hook portion from the loop portion.

According to one embodiment, loop portion 128 is non-stretch material. What is meant by non-stretch material or non-stretchable material is material that stretches less than or equal to 3% of its length when held in tension under a load of no more than 10 pounds. The non-stretch loop portion can improve the efficacy of compression on the animate body when the apparatus is in place. Loop portion 128 can be made of non-stretch material, which can be woven or non-woven fabric. Alternatively, loop portion 128 can be made by securing loop material or fabric to non-stretch backing material, which can be woven or non-woven fabric. The non-stretch backing material may be spun material. Suitable non-stretch backing materials include, but are not limited to, nylon or high density polyethylene such as Tyvek® (strong yarn linear polyethylene). The non-stretch and loop materials can be sewn, fused, or laminated together. Accordingly, outer back side portion 114 can comprise first and second materials where the first material is non-stretch material (e.g., non-stretch woven or non-woven fabric), the second material is loop material and the non-stretch material forms backing for the loop material.

The second modular member 104 or sleeve also can have a permanent antimicrobial finish to prevent mold growth, such as finishes made according to military specification MIL.STD.810D. The finish can be applied by placing the fabric in a chemical dip as is known in the art. The second modular member or sleeve can act as a blood barrier to prevent contamination of the heat exchanger and reduce transmission of bacteria from patient to patient. For example, the inner faces of the second modular member that form the pouch and contact first modular member 102 can be nylon with a durable water repellency (DWR) coating, which is typically a ½ ounce polyurethane coating.

FIG. 5A illustrates the modular portions of FIG. 4 with the first modular member inside second modular member 104 and zipper 127 closing opening 124. In this state, the apparatus is ready to apply to the portion of the body to be treated. Further, the pouch that second modular member 104 forms allows first modular member 102 to “float” therein. In other words, beyond being confined in pouch 122, there are no connections between first and second modular members 120 and 104; the first modular member is “freely supported” within the pouch. This allows some movement of the first modular member within the pouch and thus can provide a more evenly distributed compression around the gas bladder. In turn, therapy of the body being treated can be improved. Further, since the heat exchange device can move within pouch 122, there is less of a chance that coolant flow will be blocked in a portion of the heat exchange device, such as when the apparatus is improperly applied to the portion of the body being treated. For example, if an improper fold or kink occurs in the heat exchange device, the heat exchange device may self-correct its position and relieve pressure or blockage of coolant flow in the heat exchange device. Alternatively, one will appreciate from the description herein that various techniques can be used to secure the first modular member in the second modular and control the relative positioning between the members.

An exemplary use of modular therapy apparatus 100 will be made with reference to FIGS. 7A-C. This example is provided for illustration and is not intended to limit the scope of the invention. Referring to FIG. 7A, apparatus 100 is positioned adjacent to a portion of a human patient's arm to be treated with the apparatus in an open state. Apparatus 100, which is coupled to fluid circulation and pressurizing unit 180, is then wrapped around the patient's arm and the second modular member hook portion 130 along flap 120 fastened to a portion of the loop portion of member 104.

The control unit includes a mechanism for cooling and circulating a liquid coolant, which includes a reservoir for containing ice water. In a practical realization of this embodiment, the liquid is normal tap water. This liquid was cooled by placing ice into the ice box portion of the control unit, resulting in temperatures ranging typically between 40° F. and 50° F. In this connection, the control unit accepts liquid that has been returned from the heat exchange bladder 108. Before reintroducing the heat exchange liquid into bladder 108, it can be mixed with the liquid in the reservoir or it can be directed to bypass the reservoir. That is, the control unit is capable of supplying liquid at other controlled temperatures by means of mixing liquid chilled in the ice box and liquid warmed in the bladder by means of contact with an animate body and returning the mixed liquid to the bladder. The pressure of air furnished by the control unit is generally about 0.25 to 1.5 psig.

It should be noted that the invention is applicable to many other types of therapy components, and the particular liquid, its temperature and pressure will be dependent upon the design and purpose of such therapy components. This is also true of the air pressure and in some instances it is cycled between two pressures (typically between 1.5 and 0.25 psig).

Although apparatus 100 has been described with a dual bladder heat exchange device, a single bladder heat exchange device can be used. In the single bladder embodiment, the bladder is adapted circulate liquid or coolant.

Similarly, the second modular member can have various shapes to accommodate different areas of an animate body. Typically, the area of one side of the second modular member will range from about 1 to 6 square feet. In the case of the knee application, for example, this area may be up to about 6 square feet. By contrast, for an elbow, this area may be about 1 to 1.5 square ft. In various embodiments, the second modular member is a sleeve for an equine body part. The area of the side of the second modular member may be up to 10 square feet. In an exemplary case of a second modular member for treating the hind quarters of horse, the area of the side of the second modular member may be up to 20 square feet.

Thus, a set of second modular members may be used for a wide variety of treatment applications. One of skill in the art will appreciate from the description herein that the configurations of the first and second modular members may be modified to provide a large degree of variety of interchangeability. As described above, for example, each of the second modular members may be a sleeve having a pouch to receive the same or similarly-sized heat transfer devices. For larger second modular members, it may be desirable to provide a pouch that can accommodate multiple heat transfer devices. For example, the pouch may have perimeter dimensions similar to the pouches of the smaller sleeves but a larger width to accommodate the additional heat transfer devices.

FIG. 5B illustrates one variation of FIG. 5A. The embodiment of FIG. 5B, is the same at that shown in FIG. 5A with the exception that second modular member is modified (as indicated with reference numeral 104′) so that the portion of the second modular member outside and to the left side of pouch 122 is larger. That portion is indicated with reference numeral 121. In an exemplary embodiment, the respective portion has a width at least 1 inch greater than the wrap of FIG. 5A, and in various embodiments, in the range of about 1 inch to about 12 inches greater. A further seam 118′ also can be provided. The ability to enlarge the overall dimension of the second modular member, while maintaining the configuration and dimension of pouch 122 unchanged facilitates using a single heat exchange device with many differently-sized second modular members or sleeves to treat differently sized patients or different body portions. Various aspects of the invention relate to a system including a first modular member and a plurality of second modular members. The second modular members are configured for different therapy. For example, each of the second modular members may correspond to a differently-sized animate body part. In another example, each of the second modular members corresponds to a different animate body part.

Various aspects of the invention relate to a system for treatment of differently sized body members. The system includes a plurality of differently sized second modular members each having a pouch 122 of the same configuration and size and a plurality of first modular members 102, each adapted to fit in any of the pouches or each being of the same size and configuration. In other words, each of the plurality of differently sized second modular members includes a pouch of substantially the same size and shape for receiving a first modular member. Thus, the plurality of second modular members can be used interchangeably with the first modular member. In various respects, the second modular members may be used with a standard heat transfer device, such as an off-the-shelf replacement part. In another example, the second modular member can be selected based on the animate body portion being treated and combined with any one of the heat exchange devices.

One of skill in the art will understand from the description herein the manner for modifying the shape and configuration of the second modular member for different treatment applications. Examples of different sleeves for different therapies are shown in FIGS. 8-27 and described in greater detail below.

Referring to FIG. 8, another embodiment of the invention is shown and generally designated with reference numeral 200. Modular therapy apparatus 200 is the same as apparatus 100 with the exception that it is larger and its configuration is slightly modified so that it better adapted to from a sleeve around ones upper leg and knee as shown in FIGS. 9A and 9B. Accordingly flap 220, which includes a hook portion that is hidden from view, is the same as flap 120 with the exception that it is larger and its configuration is slightly modified as shown in the drawings.

Referring to FIGS. 10 and 11, another embodiment of the invention is shown and generally designated with reference numeral 300. As will be described in more detail below, apparatus 300 can be used, for example, to treat the core or torso of a human body. FIG. 10 illustrates bottom plan views of the modular portions of apparatus 300 and FIG. 11 illustrates top plan views of the modular portions of FIG. 10.

Apparatus 300 comprises first modular member 302 and second modular member 304. First modular member 302 includes gas bladder 306 and fluid or coolant bladder 308. Bladders 306 and 308 form chambers 306 a and 308 a, respectively. Except for the configuration of first modular member 302, first modular member 302 is the same as first modular member 102 and can be made in the same manner, with the exception that a plurality of connections between the walls defining the modular member or air bladder 302 can be provided.

More specifically, and with reference to FIG. 12, which a sectional view of apparatus 300, a plurality of connections between the walls defining modular member or air bladder 302 can be provided as described in U.S. Pat. No. 6,695,872 to Elkins, the disclosure of which is hereby incorporated herein by reference. Such connections can minimize or eliminate undesirable ballooning when the bladder is pressurized. In the illustrative embodiment, in which the bladders are formed by RF welding (see e.g., FIG. 12), this is simply achieved by forming some of the connections normally provided in liquid bladder 308, while sheet 350 is in place as will be described in more detail below. The result is that these connections are also formed in air bladder 306, that is, these connections are both within the liquid bladder and in the air bladder. It appears functionally as if the desired connections provided in the liquid bladder are “telegraphed” also to appear in the air bladder. These connections in the two bladders, of course, register with one another.

In the illustrative embodiment, the shape of gas pressure bladder 306 conforms to the shape of the heat exchange bladder 308. Fences or dividers in the heat exchange bladder to direct fluid flow can be also provided in the gas pressure bladder. These control fences are indicated by the reference numeral C in FIG. 12. They can be provided in bladder 306 not only for the purpose of directing the flow of a liquid or gas, but also to secure the walls defining the gas pressure bladder together at various locations within the interior of such bladder. These connections provided by the fences C can prevent the gas bladder from “ballooning” out as described above and causing the temperature control liquid bladder not to conform to the body part. These fences register with the comparable fences in the liquid bladder.

During the manufacturing process, sheets of material defining the walls 352 and 354 are RF welded together at the dot connections and if desired, at the interior fences. At a later time the wall 350 is RF welded to the other walls at the perimeter of the bladder with any interior fences being formed as needed. Such fences C will thereby be formed in both bladders providing the desired liquid flow directors in the liquid bladder and the connections in the air bladder. This RF welding will also form a common border for walls 350, 352, and 354.

The inner fences construction also can be provided in the gas bladder of the embodiment of FIGS. 20-24, which is described in detail below.

Second modular member 304 is the same as second modular member 104 with the exception that second modular member is differently configured and includes central portion 304 a, and straps or strap portions 304 b and 304 c. Strap portions 304 b and 304 c are secured to central portion 304 a as will be described in more detail below. Second modular member central portion 304 a comprises an inner or front side portion 312 and an outer or back side portion 314. Central portion 304 a can be made from various materials and can comprise inner and outer sheets of material that are sewn or fused together as previously described in connection with member 104 and can include seam 316 which defines the perimeter of pouch 322. Pouch 322 is adapted to receive first modular member 302. Strap portions 304 b and 304 c can comprise one or more layers of material. When more than one layer is used, the layers can be sewn or fused together as would be apparent to one skilled in the art.

Outer back side portion 314 of central portion 304 a has an opening 324 formed therein for receiving first modular member 302 as shown in FIG. 13A. Any suitable fastening means can be used to close opening 124. For example, zipper 327 can be provided along the sides of the opening (FIGS. 13B & C).

Second modular member 304 also includes a fastener for holding the apparatus in the desired location on the animate body. Accordingly, when the apparatus is wrapped around a portion of or the entire region being treated, the fastener holds the apparatus in place during treatment. As in the embodiments described above, a hook and loop fastener is be used in this illustrative embodiment.

Referring to FIG. 11, the loop material portion 328 of the hook and loop fastener can be integrally formed with or placed over essentially all of outer back side portion 314 of second modular member 304. Therefore, the loop material portion can cover the outer back side surface of center portion 304 a, and strap portions 304 b and 304 c (FIG. 11). Alternatively, a strip of loop material can be integrally formed with or placed over a portion or the entire length (measured from the upper to lower edge of member 304) adjacent the outer end of portion 304 c and along interface with center portion 304 a. According to one embodiment, loop portion 328 is non-stretch material and can be made in the same manner as loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens the apparatus to the animate body is shown in FIG. 10 and generally designated with reference numeral 330. Hook portion 330 is positioned on the front side portion 312 of strap 304 b and can be in the form of a single strip that extends along the outer end portion of strap 304 b or it can be integrally formed with the front side portion of 304 b. It can extend about 50% to 100% of the length of strap 304 b. Alternatively, hook portion can comprise a plurality of strips, which can be spaced from one another. Hook material portions 330 also are provided along the inner end portions of straps 304 b and 304 c. These portions are shown in dashed line in FIG. 10.

In the illustrative embodiment, the active areas of the hook and loop fastener on the outer end portions straps 304 b and 304 c are outside the seam forming pouch 122. When compression increases, the forces may tend to resolve as shear forces as compared to other forces that can peel the hook portion from the loop portion. The hook and loop fastener that operates between the inner end portions of strap portions 304 b and 304 c and center portion 304 a facilitate removal of the strap portions. This, in turn, facilitates replacement of either or both straps or repositioning of the straps. For example, the straps can be portioned as shown in FIG. 13B, which may be preferred when treating the upper torso of a patient. Alternatively, the straps can be removed and repositioned as shown in FIG. 13C, which may be preferred when treating the lower portion of the patient's torso.

FIGS. 14A-D diagrammatically depict use of the apparatus 300 where FIG. 14A show a first step in wrapping the apparatus around the waist or lower portion of the torso of a patient, FIG. 14B shows securing the apparatus in place, and FIG. 14C shows the apparatus being in its final position and ready for use. FIG. 14D shows the apparatus with the straps repositioned and the apparatus being wrapped around the upper torso of the patient.

Referring to FIG. 15, another embodiment of the invention is shown and generally designated with reference numeral 400. Modular therapy apparatus 400 can be used, for example, to treat an ankle and/or foot of a patient. FIG. 16 illustrates top plan views of modular portions of apparatus 400 and FIG. 17 illustrates bottom views of the modular portions of apparatus 400.

Apparatus 400 comprises first modular member 402 and second modular member 404. First modular member 402 includes gas bladder 406 and fluid or coolant bladder 408. Bladders 406 and 408 form chambers 406 a and 408 a, respectively. Except for the configuration of first modular member 402, first modular member 402 is the same as first modular member 102 and can be made in the same manner.

Second modular member 404 is the same as second modular member 104 with the exception that second modular member is differently configured, has differently positioned hook portions and has heel alignment marker 405. Accordingly, member 404 can be made from various materials and can comprise inner and outer sheets of material that are sewn or fused together as previously described in connection with member 104 and can include seam 416, which in combination with seams 418, defines the perimeter of pouch 422. Pouch 422 is adapted to receive first modular member 402.

Outer back side portion 414 has an opening 424 formed therein for receiving first modular member 402 as shown in FIG. 16. Zipper 427 can be provided along the sides of the opening (FIG. 18C).

Second modular member 404 also includes a fastener for holding the apparatus in the desired location on the animate body and can include the hook and loop fastener system described in connection with apparatus 100. Referring to FIG. 11, the loop material portion 428 of the hook and loop fastener can be integrally formed with or placed over essentially all of outer back side portion 414 of second modular member 404. Alternatively, a strip of loop material can be integrally formed with or placed over a portion of back side portion 414 that would cooperate with the hook portions in accordance with FIGS. 17 and 19A-C. According to one embodiment, loop portion 428 is non-stretch material and can be made in the same manner as loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens the apparatus to the animate body is shown in FIG. 17 and generally designated with reference numeral 430. Hook portions 430 can have a width of about 4 inches. In the illustrative embodiment, the active areas of the hook and loop fastener are outside the seams forming pouch 422, which can provide similar advantages to those described above regarding force resolution when the apparatus is under compression.

FIGS. 18A-C illustrate inserting the modular member 402 into modular member 404. where FIG. 18A illustrates a first stage of inserting modular member 402 into modular member 404. FIG. 18B illustrates another stage portion into the other and FIG. 18C illustrates member 402 fully inserted and zipper 327 closed.

FIGS. 19A-D illustrate use of the embodiment of FIG. 10. First one places one's foot on inner side portion 412 with one's heel aligned along U-shaped marker 405. Flap V is wrapped over the foot and flap W secured thereto with hook portion 430 FIGS. 19A & B). Flap X is wrapped around the ankle and leg and then flap Y is wrapped thereover and secured thereto with hook portion 430 (FIG. 19C). Flap Z is then wrapped around the leg and over flap Y and secured thereto with hook portion 430 (FIG. 19D).

Referring to FIG. 20, another embodiment of the invention is shown and generally designated with reference numeral 500. Apparatus 500 can be used to treat the shoulder of a patient. FIG. 21 illustrates top views of the modular members of the apparatus 500 and FIG. 22 illustrates bottom views of the modular members shown in FIG. 21.

Apparatus 500 comprises first modular member 502 and second modular member 504. First modular member 502 includes gas bladder 506 and fluid or coolant bladder 508. Bladders 506 and 508 form chambers 506 a and 508 a, respectively.

First modular member 502 is the same as first modular member 102 except for the configuration of modular member 502, including flap portions 562, and that it can include the inner fence construction described above in connection with the embodiment of FIGS. 10-14. Modular member 502 also differs from modular member 102 in that it includes a coupling mechanism for coupling these flap portions. More specifically, flap portions 562 are coupled to one another through elastic cord 560, which is laced through holes formed in first modular member 502. The elastic cord substantially maintains flaps 562 in the closed position shown in FIG. 21 when bladder 506 is inflated and fluid circulated through bladder 508.

Second modular member 504 is the same as second modular member 104 with the exception that second modular member is differently configured and includes central portion 504 a, and straps or strap portions 504 b, 504 c, and 504 d. Strap portions 504 b, c & d are secured to central portion 504 a as will be described in more detail below. Second modular member central portion 504 a comprises an inner or front side portion 512 and an outer or back side portion 514. The arm sling 540 can be coupled to second modular member 504 through a plurality of snap connectors “S” or any other suitable connector including but not limited to hook and loop fasteners. Central portion 504 a can be made from various materials and can comprise inner and outer sheets of material that are sewn or fused together as previously described in connection with member 104 and can include seam 516, which in combination seam 518, define the perimeter of pouch 522. Pouch 522 is adapted to receive first modular member 502. Strap portions 504 b, c, and d can comprise one or more layers of material. When more than one layer is used, the layers can be sewn or fused together as would be apparent to one skilled in the art.

Outer back side portion 514 has an opening 524 formed therein for receiving first modular member 502 as shown in FIG. 16. Zipper 527 can be provided along the sides of the opening (FIG. 18C).

Second modular member 504 also includes a fastener for holding the apparatus in the desired location on the animate body and can include the hook and loop fastener system described in connection with apparatus 100. Referring to FIG. 21, the loop material portion 528 of the hook and loop fastener can be integrally formed with or placed over essentially all of outer back side portion 514 of second modular member 504. Alternatively, a strip of loop material can be integrally formed with or placed over a portion of back side portion 514 that would cooperate with the hook portions described below. According to one embodiment, loop portion 528 is non-stretch material and can be made in the same manner as loop portion 128 as described above.

The hook material portion of the hook and loop fastener that fastens the apparatus to the animate body and generally designated with reference numeral 530. The hook portion of strap portion 504 b can comprise two sections, each having a length extending along the length of the strap of about 4 or 5 inches. These sections can be spaced apart by about 1 inch to facilitate or improve flexibility of the end portion of the strap. In this manner, the strap can be readily folded to provide length adjustment for differently sized users. In the illustrative embodiment, the active areas of the hook portion of the hook and loop fastener are outside the seams forming pouch 522, which can provide similar advantages to those described above regarding force resolution when the apparatus is under compression.

FIGS. 23A-D illustrate coupling the modular members 502 and 504 where FIG. 23A illustrates aligning modular member 502 with opening 524 in second modular member outer back side portion 514. FIGS. 23B and C show insertion of modular member 502 into modular member 504 and FIG. 24D shows back side portion 514 closed and zipped up.

FIGS. 24A-D diagrammatically illustrate use of apparatus 500 where FIG. 24A shows a first stage in pulling the apparatus over the patient's arm and toward the patient's shoulder. FIG. 24B illustrates positioning the apparatus over the shoulder of the patient and securing hook portions of straps 504 c and 504 d to portions of central portion 504 a which are constructed with loop material to secure apparatus 500 to the patient's arm. Strap 504 b is then pulled under the patient's other shoulder and a portion of its hook portion is ready to be fastened to the loop material of central portion 504 a (FIG. 24C). In FIG. 24C, the end portion of strap 504 b is folded back along the space between hook portions 530 and secured in that position by tucking into a pocket designed to accept it. This facilitates shortening the strap for smaller patients. The end portion of strap 504 b can be unfolded to extend the length of the strap for larger patients as shown in FIG. 24D. FIG. 24D also shows optional strap 640, which can be used to hold up the lower arm of the patient. Strap 540 can have a hook portion on one end and snaps at the opposite end so that the hook portion can be fastened to loop material the outer side portion 514 or second modular member 504 and the snaps can be fastened to the snaps on modular portion 504.

Referring to FIG. 25, a further embodiment of the invention is shown and generally designated with reference numeral 600. Apparatus 600 is especially suited for equine applications. In FIG. 25, apparatus 600 is shown wrapped around at horse's leg. The therapy fluids are delivered though the hose 601, which has one end coupled to apparatus 600 through manifold 110 and its other end coupled to a therapy fluid circulation control unit such as control unit 160. Accordingly, conduit 601 can have three channels for fluid flow (e.g., two for liquid or gas coolant and one for gas). When a single apparatus is used, conduit 601 is directly fluidly coupled to a fluid circulation control unit. However, when it is desired to treat two legs, a Y-connector can be provided as shown in FIG. 25. One such Y-connector is diagrammatically shown and indicated with reference numeral 603. In this case, another conduit such as conduit 605 fluidly couples the Y-connector 603 with the circulation control unit (not shown). The Y-connector facilitates fluidly coupling each conduit 601, which is fluidly coupled to a respective apparatus 600 through a manifold 110, to the circulation control unit so that a plurality of legs (i.e., 2) can be treated at the same time.

FIG. 26 illustrates bottom plan views of modular portions of apparatus 600 and FIG. 17 illustrates top views of the modular portions of apparatus 600. Apparatus 600 comprises first modular member 602 and second modular member 604. First modular member 602 includes gas bladder 606 and fluid or coolant bladder 608. Bladders 606 and 608 form chambers 606 a and 608 a, respectively. Except for the configuration of first modular member 602, first modular member 602 is the same as first modular member 102 and can be made in the same manner.

Second modular member 604 is the same as second modular member 104 with the exception that second modular member is differently configured including differently configured hook portions 630. Accordingly, member 604 can be made from various materials and can comprise inner and outer sheets of material that are sewn or fused together as previously described in connection with member 104 and can include seam 616, which defines the perimeter of pouch 622. Pouch 622 is adapted to receive first modular member 602. Inner side portion 612 is placed against the portion of the body being treated and outer back side portion 614 has an opening formed therein for receiving first modular member 602. The opening is shown closed with zipper 627 in FIG. 27.

Second modular member 604 also includes a fastener for holding the apparatus in the desired location on the animate body and can include the hook and loop fastener system described in connection with apparatus 100. Referring to FIG. 27, the loop material portion 628 of the hook and loop fastener can be integrally formed with or placed over essentially all of outer back side portion 614 of second modular member 604. Alternatively, it can be integrally formed with or placed over the right portion of zipper 627 or the side of zipper 627 opposite flaps 620. According to one embodiment, loop portion 628 is non-stretch material and can be made in the same manner as loop portion 128 as described above.

The hook material portion(s) of the hook and loop fastener that fastens the apparatus to the animate body is shown in FIG. 26 and generally designated with reference numeral 630. Hook portions are integrally formed with or secured to flaps 620, which extend outward form seam 618. Hook portions 630 are can have a width of about 3 inches and a length of about 12 to 30 inches.

Regarding manufacture, it can be specialized to make the first modular member, second modular member and any desired configuration thereof. Further, a plurality of any of apparatus 200, 300, 400, 500, and 600 can be provided with differently sized second modular members, but with same sized pouches and same sized first modular members to facilitate component interchangeability in a manner similar to that described in connection with FIG. 5B.

Variations and modifications of the devices and methods disclosed herein will be readily apparent to persons skilled in the art. As such, it should be understood that the foregoing detailed description and the accompanying illustrations, are made for purposes of clarity and understanding, and are not intended to limit the scope of the invention, which is defined by the claims appended hereto. Any feature described in any one embodiment described herein can be combined with any other feature of any of the other embodiment whether preferred or not. 

What is claimed is:
 1. A heat exchange apparatus comprising: a first bladder having a first opening; a first tube adapted and configured for positioning within the first opening of the first bladder and in communication with an interior volume of the first bladder; a second bladder adjacent to the first bladder, the second bladder having a first opening and a second opening; a first tube and a second tube adapted and configured for positioning within the first opening and the second opening of the second bladder and in communication with an interior volume of the second bladder; a manifold having a first connection port, a second connection port and a third connection port and adapted and configured to receive the first tube of the first bladder and the first and second tubes of the second bladder and to provide a fluid pathway between a first connection port and the first tube of the first bladder, a second connection port and the first tube of the second bladder and a third connection port and the second tube of the second bladder.
 2. The heat exchange apparatus of claim 1, further comprising: a fluid circulation and pressurizing unit; and a hose having a first end connector adapted and configured to couple to the first connection port, the second connection port and the third connection port of the manifold and a second end connector adapted and configured to couple to the fluid circulation and pressurizing unit.
 3. The heat exchange apparatus of claim 1 further comprising a fluid circulation and pressurizing unit adapted and configured to provide air to the first bladder via the first connection port and to supply water to and return water from the second bladder via the second connection port and the third connection port.
 4. The heat exchange apparatus of claim 3 wherein the first connection port is adjacent to a connection port used to supply water to the second bladder.
 5. The heat exchange apparatus of claim 3 wherein the first connection port is adjacent to a connection port used to return water from the second bladder.
 6. The heat exchange apparatus of claim 1, further comprising: a fluid circulation and pressurizing unit; and a hose having a first end connector adapted and configured to couple to the first connection port, the second connection port and the third connection port of the manifold and a second end in communication with the fluid circulation and pressurizing unit.
 7. The heat exchange apparatus of claim 2 wherein the fluid circulation and pressurizing unit is adapted and configured to provide air to the first bladder, supply water to the second bladder and receive water from the second bladder.
 8. The heat exchange apparatus of claim 1 wherein the first bladder and the second bladder are sized and shaped so as to be adapted to at least partially encircle a portion of a user's body while providing therapy to at least a portion of the at least partially encircled portion of the user's body.
 9. The heat exchange apparatus of claim 8 further comprising a modular member having an opening and a pouch sized and shaped to receive the first bladder and the second bladder wherein the modular member has a fastener to hold the modular member in place relative to the portion of the user's body receiving therapy.
 10. The heat exchange apparatus of claim 8 wherein the portion of the user's body is one of a foot, a foot and an ankle, a lower leg, an upper leg, a knee, and a shoulder.
 11. The heat exchange apparatus of claim 8 wherein the manifold is configured to mate with a curvature of a portion of the user's body receiving therapy from the first and the second bladder.
 12. The heat exchange apparatus of claim 1, wherein the second bladder further comprises a first surface and a second surface wherein the first surface is directed towards the first bladder and the second surface is directed towards a user when the second bladder is in use to deliver therapy to a portion of the user's body.
 13. The heat exchange apparatus of claim 12 wherein the first surface has a first side in communication with a fluid contained within the first bladder and a second side in communication with a fluid contained in the second bladder.
 14. The heat exchange apparatus of claim 1 wherein a perimeter of the first bladder is aligned with a perimeter of the second bladder.
 15. The heat exchange apparatus of claim 1 wherein the length of the first tube configured for use with the first bladder and the length of the first tube and the length of the second tube configured for use in the second bladder positions the manifold adjacent to the bladder perimeter.
 16. The heat exchange apparatus of claim 1 wherein the length of the first tube configured for use with the first bladder and the length of the first tube and the length of the second tube configured for use in the second bladder positions the manifold in a position spaced apart from the bladder perimeter.
 17. A heat exchange apparatus comprising: a first bladder having a first opening; a second bladder having a first opening and a second opening; a manifold having a first connection port with a first quick disconnect fitting, a second connection port with a second quick disconnect fitting, and a third connection port with a third quick disconnect fitting; a first tubular member configured to provide fluid communication from the first quick disconnect fitting to an interior volume of the first bladder via the first opening in the first bladder; a second tubular member configured to provide fluid communication from the second quick disconnect fitting to an interior volume of the second bladder via the first opening in the second bladder; and a third tubular member configured to provide fluid communication from the third quick disconnect fitting to an interior volume of the second bladder via the second opening in the second bladder.
 18. The heat exchange apparatus of claim 17, further comprising: a fluid circulation and pressurizing unit; and a hose having a first end connector adapted and configured to couple to the first quick disconnect fitting, the second quick disconnect fitting and the third quick disconnect fitting of the manifold and a second end connector adapted and configured to couple to the fluid circulation and pressurizing unit.
 19. The heat exchange apparatus of claim 17, further comprising: a fluid circulation and pressurizing unit; and a hose having a first end connector adapted and configured to couple to the first quick disconnect fitting, the second quick disconnect fitting and the third quick disconnect fitting of the manifold and a second end in communication with the fluid circulation and pressurizing unit.
 20. The heat exchange apparatus of claim 19 wherein the fluid circulation and pressurizing unit is adapted and configured to provide air to the first bladder and water to the second bladder.
 21. The heat exchange apparatus of claim 17 wherein when the first bladder and the second bladder are sized and shaped so as to be adapted to at least partially encircle a portion of a user's body while providing therapy to at least a portion of the at least partially encircled portion of the user's body.
 22. The heat exchange apparatus of claim 21 further comprising a modular member having an opening and a pouch sized and shaped to receive the first bladder and the second bladder wherein the modular member has a fastener to hold the modular member in place relative to the portion of the user's body receiving therapy.
 23. The heat exchange apparatus of claim 21 wherein the portion of the user's body is one of a foot, a foot and an ankle, a lower leg, an upper leg, a knee, and a shoulder.
 24. The heat exchange apparatus of claim 17, wherein the second bladder further comprises a first surface and a second surface wherein the first surface is directed towards the first bladder and the second surface is directed towards to a user when the second bladder is in use to deliver therapy to a portion of the user's body.
 25. The heat exchange apparatus of claim 24 wherein the first surface has a first side in communication with a fluid contained within the first bladder and a second side in communication with a fluid contained in the second bladder.
 26. The heat exchange apparatus of claim 17 wherein the length of the first tubular member, the second tubular member and the third tubular member positions the manifold adjacent to the bladder perimeter.
 27. The heat exchange apparatus of claim 17 wherein the length of the first tubular member, the second tubular member and the third tubular member positions the manifold in a position spaced apart from the bladder perimeter. 